Microcirculatory Vasomotor Changes in Type 2 Diabetes With Peripheral Neuropathy (NEUROMICRO)

November 12, 2020 updated by: University of Avignon

Microcirculatory Vasomotor Function in Response to Acute Exercise in Type 2 Diabetes With Peripheral Neuropathy

Microcirculatory flow is subject to cyclic changes under the influence of heart rate, respiration, myogenic activity, neurogenic factors and endothelial factors. Microcirculatory oscillations (vasomotion) contribute significantly to tissue perfusion. Vasomotion analysis allowed to discriminate normoglycemic subjects, prediabetic subjects and diabetic subjects. Furthermore, changes in vasomotion can precede the emergence of global signs of microangiopathy complications in type 2 diabetes. In fact, few studies reported impaired vasomotion in type 2 diabetes with peripheral neuropathy. Vasomotion analysis after vasodilator (6-min walking test and hyperthermia) and after vasoconstrictor (foot lowering) stimulus could be an effective diagnostic tool to sharpen the diagnostic.

Objectives and Methodology: to study vasomotion at baseline and after exercise, hyperthermia and foot lowering within 3 groups of patients: diabetic without peripheral neuropathy, diabetic with subclinical peripheral neuropathy and diabetic with peripheral neuropathy and one group of sex- age- and body mass index-matched healthy control subjects.

All the subjects will benefit from a clinical, anthropometric, level of physical activity and biological evaluations. Type 2 diabetes participants will benefit from neuropathy evaluation. In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All the subjects will benefit from a:

  • clinical: diabetes duration, treatments
  • anthropometric: weight, height, BMI
  • level of physical activity by means of the International Physical Activity Questionary, pedometers and the 6 minutes walking test
  • biological evaluations: glycemia, HbA1C, lipids, high sensitive C-reactive protein, fibrinogen, 25(OH)D, creatinine, albumine Type 2 diabetes participants will benefit from neuropathy evaluation: sensory tests by means of Semmes-Weinstein monofilament and of Nerve Check, amplitude and velocity sural nerve and neuropathic symptom score (NSS) In addition, cutaneous microcirculation (perfusion and vasomotion) by means of Laser Doppler Flowmetry and Laser Speckle Imaging will be recorded at rest and after different stimuli (exercise, hyperthermia and foot lowering).

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84 000
        • Centre Hospitalier Henri Duffaut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For diabetic patients, HbA1C >6.5 and diabetes duration >5years
  • For healthy control no diabetes mellitus, no cardiovascular or renal pathology

Exclusion Criteria:

  • nondiabetic neuropathy
  • on medication known to affect microcirculation
  • presence of active foot ulcer or wound healing history <3months
  • inability to walk 6 minutes
  • alcohol consumption of more than 3 units per day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-neuropathy

Type 2 diabetic without neuropathy:

  • Negative findings on Semmes-Weinstein monofilament
  • Neuropathy symptom score (NSS) <3
  • Negative findings on Nerve Check and Diabetic Peripheral Neuropathy check.

Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging:

  • "rest" cutaneous microcirculation (perfusion and vasomotion)
  • "Exercise" cutaneous microcirculation (perfusion and vasomotion)
  • "Foot lowering" cutaneous microcirculation (perfusion and vasomotion)
  • "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion)
  • blood sampling
  • heart rate variability at rest
  • pedometer during 4 days
  • international Physical Activity Questionary
  • Qualify of Life questionary (EQVOD)
Other: "Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position
Other: "Exercise"
Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
Other: "Foot lowering"
Cutaneous perfusion and vasomotion assessment after foot lowering
Other: "Hyperthermia"
Cutaneous perfusion and vasomotion assessment during hyperthermia
Experimental: Neuropathy

Type 2 diabetic with neuropathy

  • Positive findings on Semmes-Weinstein monofilament
  • Neuropathy symptom score (NSS) >3
  • Positive findings on Nerve Check and Diabetic Peripheral Neuropathy check.

Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging:

  • "rest" cutaneous microcirculation (perfusion and vasomotion)
  • "Exercise" cutaneous microcirculation (perfusion and vasomotion)
  • "Foot lowering" cutaneous microcirculation (perfusion and vasomotion)
  • "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion)
  • blood sampling
  • heart rate variability at rest
  • pedometer during 4 days
  • international Physical Activity Questionary
  • Qualify of Life questionary (EQVOD)
Other: "Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position
Other: "Exercise"
Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
Other: "Foot lowering"
Cutaneous perfusion and vasomotion assessment after foot lowering
Other: "Hyperthermia"
Cutaneous perfusion and vasomotion assessment during hyperthermia
Experimental: Controls

matched for age, sexe and BMI with diabetic patients.

Interventions by means of Laser Doppler Flowmetry and Laser Speckle Imaging:

  • "rest" cutaneous microcirculation (perfusion and vasomotion)
  • "Exercise" cutaneous microcirculation (perfusion and vasomotion)
  • "Foot lowering" cutaneous microcirculation (perfusion and vasomotion)
  • "Hyperthermia" cutaneous microcirculation (perfusion and vasomotion)
  • blood sampling
  • heart rate variability at rest
  • international Physical Activity Questionary
  • Qualify of Life questionary (EQVOD)
Other: "Rest"
Cutaneous perfusion and vasomotion assessment at rest in supoine position
Other: "Exercise"
Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
Other: "Foot lowering"
Cutaneous perfusion and vasomotion assessment after foot lowering
Other: "Hyperthermia"
Cutaneous perfusion and vasomotion assessment during hyperthermia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in average spectral amplitude of the entire frequency range between baseline and after stimulus
Time Frame: Cutaneous blood flow will be recorded during 20 minutes at rest, 10 minutes after foot lowering, 15 minutes after exercise and 20 minutes during hyperthermia
Spectral analysis by wavelet analysis
Cutaneous blood flow will be recorded during 20 minutes at rest, 10 minutes after foot lowering, 15 minutes after exercise and 20 minutes during hyperthermia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Avignon

Investigators

  • Principal Investigator: Eric Benamo, MD, Centre Hospitalier Avignon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAPV-012019-AVJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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